To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: A; Drug: LivaloVA; Drug: LivaloV

Study type: Interventional

Funder types: Industry

Identifiers

NCT05351840

JWP-PVA-101

Details and patient eligibility

About

To evaluate and compare the pharmacokinetic interactions and safety of multiple dose of Treatment A and Treatment B alone and in combination

Full description

The objective of this study was to evaluate pharmacokinetic characteristics and safety after oral concurrent administration of Treatment A and Treatment B compared to each single administration in Healthy volunteers.

Enrollment: 31 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers, aged between 19 to 45 years (both inclusive) at the screening.
• Subjects who are informed of the investigational nature of this study, and voluntarily agree to participate in this study and signs informed consent

Exclusion criteria

• Subjects who have a clinically significant past or present medical history of hepato-biliary, renal, gastrointestinal, respiratory, hematologic/neoplastic, endocrine, urologic, psychiatric, musculoskeletal, immunologic, Otorhinolaryngological, and cardiovascular diseases.
• Subjects who have a medical history and/or condition that is considered to be dangerous to take the study drug.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

Period I

Experimental group

Description:

Subject will receive Drug(LivaloV), then take it by oral, once-daily form Day 1 to Day 7

Treatment:

Drug: LivaloV

Period II

Experimental group

Description:

Subject will receive Drug(A), then take it by oral, once-daily form Day 14 to Day 23

Treatment:

Drug: A

Period III

Experimental group

Description:

Subject will receive Drug(LivaloVA), then take it by oral, once-daily form Day 24 to Day 30

Treatment:

Drug: LivaloVA